Apparatus and formulation for treating mouth ulcers

ABSTRACT

A kit that is made of an apparatus comprising a bottle and a nozzle sprayer, and a pharmaceutical formulation comprising dyclonine HCL, triamcinolone, dicyclomine, and dental powder. 
     A method for treating mouth ulcers comprising administering to a patient a formulation comprising dyclonine HCL, triamcinolone, dicyclomine, and dental powder to an affected area.

CROSS-REFERENCE TO RELATED APPLICATIONS

This present application claims the priority of U.S. Provisional PatentApplication Ser. No. 62/590,949 filed Nov. 27, 2017; the entire contentand scope of which are incorporated herein by reference.

FIELD

The present disclosure generally relates to a kit and a pharmaceuticalformulation for treating recurrent mouth ulcers.

BACKGROUND

Mouth ulcers are problematic to treat due to the painful and awkwardnature of applying known treatments. A kit and a pharmaceuticalformulation may be used that facilitates treatment in a convenient, painfree manner.

SUMMARY

A kit that is made of an apparatus that is made of a bottle, anadjustable nozzle, and a sprayer, and is filled with a pharmaceuticalformulation comprising dyclonine HCL, triamcinolone, dicyclomine, anddental powder.

A method for treating mouth ulcers comprising administering to a patienta formulation comprising dyclonine HCL, triamcinolone, dicyclomine, anddental powder to an affected area in one spray four times a day forthirty days, or until the symptoms have resolved.

A method for treating mouth ulcers comprising administering to a patienta formulation comprising an oral anesthetic, a corticosteroid, ananticholinergic, and dental powder to an affected area in one spray fourtimes a day for thirty days, or until the symptoms have resolved.

DESCRIPTION OF THE FIGURES

The features and components of the following figures are illustrated toemphasize the general principles of the present disclosure and are notnecessarily drawn to scale. Corresponding features and componentsthroughout the figures may be designated by matching referencecharacters for the sake of consistency and clarity.

FIG. 1 is an apparatus with an adjustable nozzle in the stored position.

FIG. 2 is an apparatus with an adjustable nozzle in the use position.

FIG. 3 is an apparatus containing a pharmaceutical formulation.

DETAILED DESCRIPTION

The present disclosure will now be described more fully hereinafter withreference to the accompanying drawings, in which some, but not allembodiments of the disclosure are shown. Indeed, this disclosure may beembodied in many different forms and should not be construed as limitedto the embodiments set forth hereinafter; rather, these embodiments areprovided so that this disclosure will satisfy applicable legalrequirements. Like numbers refer to like elements throughout.

The present disclosure recognizes that dentists are very limited on themedications they can prescribe for aphthous stomatitis or mouth ulcersand that most over-the-counter (“OTC”) products only treat the symptomsnot the cause. About half of the population get mouth ulcers. There arevarious forms of mouth ulcers, and some usually heal within a couple ofweeks and do not leave scars. For most people, they are just annoying.But some people get larger sores (almost one-half inch across orlarger). These take longer to heal, can be painful, and may leave scars.These ulcers may be so uncomfortable that it is sometimes hard to eat orspeak.

There are many different types of mouth sores than can develop around orin the mouth. Some are painful, some are unsightly and some may be asign of something more serious.

Mouth ulcers are usually round or oval sores that commonly appear insidethe mouth on the cheeks, lips, tongue. They can be white, red, yellow orgrey in color and swollen. It's possible to have more than one mouthulcer at a time and they may spread or grow.

Mouth ulcers shouldn't be confused with cold sores, which are smallblisters that develop on the lips or around the mouth. Cold sores oftenbegin with a tingling, itching or burning sensation around your mouth.Canker sores are small, white or yellow, center lesions with a redborder. They develop in the mouth on the tongue, inside cheek areas,lips, gum line and throat area. They are not contagious. Cold sores mayappear as clusters of red, raised blisters outside the mouth—typicallyaround the lips, but they can develop under the nose or under the chin.Cold sores may be highly contagious.

Typically, only the symptoms of mouth ulcers can be treated. Treatmentis meant to alleviate the symptoms and the pain of an ulcer. Treatmentdoes not stop a person from having mouth sores again.

Large or very painful sores may be treated with steroid medicines.Steroid medications may be gels or creams. These gels or creams areplaced on the sores. Many steroid medicines do help make the ulcers orthe sores heal faster. Steroid medicines also inhibit the growth of thesores. In addition to creams and gels, steroids medicines may also beinjected. There are also a few medicines you can take by mouth, but thisis for the most serious cases. However, these creams, ointments, andrinses are often either painful or awkward to apply.

The present disclosure illustrates a treatment of mouth ulcers in amanner that does not cause pain or discomfort to a patient. Thetreatment requires an apparatus, which delivers a pharmaceuticalformulation 200.

The apparatus is shown in the Figures. The apparatus contains a bottle100 where the formulation 200 is stored. The apparatus also contains anadjustable nozzle 300 and a sprayer 400 by which the apparatus may spraythe pharmaceutical formulation 200 to the affected areas. Thepharmaceutical formulation 200 may be applied without touching theinflamed, painful areas.

Presently, there is no multi-ingredient ulcer medication in the US. Thepharmaceutical formulation 200 of the present disclosure uses thecombination of four ingredients: dyclonine HCL, triamcinolone,dicyclomine, and dental powder.

Dyclonine HCL is an oral anesthetic that is the active ingredient ofSucrets, which is an OTC throat lozenge for sore throats. Dyclonine HCLis also found in some varieties of the Cepacol sore throat spray.Dyclonine HCL is a local anesthetic and in the present pharmaceuticalformulation 200 is in the form of a hydrochloride salt for topicalapplication.

Dyclonine HCL has also been used as a self-medication for the short-termrelief of minor sore throat pain and mouth and gum irritation. DyclonineHCL has also been used in fixed combination with menthol asself-medication for temporary relief of occasional minor irritation,pain, or soreness of mouth or throat, as well as for treatment forcoughs associated with a cold or inhaled irritants.

Dyclonine HCL has also been used as a local anesthetic agent prior tolaryngoscopy, bronchoscopy, esophagoscopy, or endotracheal intubation.However, oral solutions no longer are commercially available in the US.

Dyclonine HCL may be administered orally as a lozenge. When used as alozenge, it should be allowed to slowly dissolve in the mouth. Thepatient should not bite or chew it.

Adults may take 1 lozenge in the amount of 1.2 mg, 2 mg, or 3 mg. Apatient may repeat after 2 hours if necessary.

Traditionally, Dyclonine HCL was provided in a tablet or capsule. In thepresent formulation, the dyclonine is preferably in dry powder form tofacilitate mixture with the other pharmaceutical compounds as well as tofacilitate the apparatus in spraying the pharmaceutical formulation 200on the affected areas.

Dyclonine HCL may be provided in the pharmaceutical formulation 200 inany amount ranging between 0.2 mg to 2 g. In one aspect, the amount ofDyclonine HCL in the formulation is 100 mg. In one aspect, the amount ofDyclonine HCL in the pharmaceutical formulation 200 is an amount between75 mg and 125 mg.

Triamcinolone is a synthetic corticosteroid and derivative of cortisol(hydrocortisone) and is also known as1-dehydro-9α-fluoro-16α-hydroxyhydrocortisone or9α-fluoro-16α-hydroxyprednisolone as well as9α-fluoro-11β,16α,17α,21-tetrahydroxypregna-1,4-diene-3,20-dione.

Triamcinolone acetonide is a synthetic corticosteroid used topically totreat various skin conditions, to relieve the discomfort of mouth soresand intraarticularly by proceduralists to treat various jointconditions.

Triamcinolone is used to treat a variety of skin conditions (e.g.,eczema, dermatitis, allergies, rash). Triamcinolone reduces theswelling, itching, and redness that can occur in these types ofconditions. Triamcinolone is a medium-to strong-potency corticosteroid.

Triamcinolone is an intermediate-acting synthetic glucocorticoid givenorally, by injection, by inhalation, or as a topical ointment or cream.

Triamcinolone is used to treat a number of different medical conditions,such as eczema, Lichen sclerosus, psoriasis, arthritis, allergies,ulcerative colitis, lupus, sympathetic ophthalmia, temporal arteritis,uveitis, ocular inflammation, Urushiol-induced contact dermatitis,aphthous ulcers (usually as triamcinolone acetonide), visualizationduring vitrectomy and the prevention of asthma attacks. It will nottreat an asthma attack once it has already begun. Triamcinolone has alsobeen used off-label for macular degeneration.

Different triamcinolone derivatives are available, including acetonide,benetonide, furetonide, hexacetonide and diacetate. Triamcinoloneacetonide is a more potent type of triamcinolone, being about eighttimes as effective as prednisone.

Triamcinolone should only be used on the skin. Under traditional uses,it is not used on the face, groin, or underarms unless directed by adoctor.

Under traditional applications and treatments, before applyingtriamcinolone, the administrator should wash and dry his or her hands.Before the medication is applied, the patient should clean and dry theaffected area. The administrator should apply a thin film of themedication to the affected area and gently rub in, usually 2 to 4 timesdaily or as directed by a physician. It is also unwise to cover, bandageor wrap the area unless directed to do so by a physician. Triamcinoloneshould not be applied to the diaper area on an infant, nor used intight-fitting diapers or plastic pants. After applying the medication,the administrator must wash his or her hands—unless the medication totreat the hands. When applying this medication near the eyes, theadministrator should avoid getting it in the eyes of the patient as thismay worsen or cause glaucoma. The nose or mouth should also be avoided.If a patient gets triamcinolone in his or her eyes, nose, or mouth, heor she should rinse with plenty of water. triamcinolone should only beused for the condition prescribed. Triamcinolone should not be usedlonger than prescribed.

Since administration of triamcinolone can be problematic, the presentdisclosure is an improvement on the delivery of triamcinolone to anaffected area. Triamcinolone, in a dry, powder form, may be mixed withdyclonine HCL, dicyclomine, and dental powder yielding a dry powderform. The sprayer 400 from the apparatus will apply the pharmaceuticalformulation 200 in a manner that is not painful nor inconvenient orawkward.

The pharmaceutical formulation 200 may contain an amount oftriamcinolone ranging in any amount from 0.1 g to 1 g. In one aspect,the pharmaceutical formulation 200 contains 50 mg. In one aspect, thepharmaceutical formulation 200 contains an amount between 40 mg and 60mg. The triamcinolone should be in a dry, powder form to blend with theother ingredients of the pharmaceutical formulation 200 to allow thesprayer 400 spray the pharmaceutical formulation 200 in dry powder form.

Dicyclomine belongs to a class of drugs known asanticholinergics/antispasmodics. Anticholinergics are a broad group ofmedicines that act on the neurotransmitter, acetylcholine. They are alsocalled antispasmodics.

By blocking the action of acetylcholine, anticholinergics preventimpulses from the parasympathetic nervous system from reaching smoothmuscle and causing contractions, cramps or spasms. Anticholinergics areused in the treatment of some gastrointestinal and bladder conditions.Anticholinergics may also be used in the treatment of some respiratoryor movement disorders.

Dicyclomine affects specific muscles in the stomach and intestinescalled the smooth muscles. Dicyclomine helps to relax these muscles torelieve the spasms that functional bowel disorders cause in parts of thedigestive system. Dicyclomine is used to treat spasms in the stomachcaused by functional bowel disorders such as irritable bowel syndrome.

Dicyclomine in an oral tablet may cause drowsiness. A patient takingdicyclomine shouldn't do anything that requires him or her to bementally alert, such as driving or operating machinery, until he or sheknows how this drug affects him or her. Dicyclomine drug may also causeother side effects.

Antacids lower the absorption of dicyclomine. Dicyclomine may affect theabsorption of other products such as levodopa, certain azole anti-fungaldrugs (ketoconazole, itraconazole), slowly-dissolving forms of digoxin,among others. If a patient is taking either ketoconazole oritraconazole, he or she should take it at least 2 hours beforedicyclomine. Many other drugs that also cause dry mouth and constipationmay interact with anticholinergics/antispasmodics such as dicyclomine.

Dicyclomine is usually provided as a capsule, tablet, or liquid.

The present pharmaceutical formulation 200 may include ananticholinergic or antispasmodic. In one aspect, the anticholinergenicis dicyclomine.

Since absorption of dicyclomine may be affected by other compounds, theapplication of the pharmaceutical formulation 200 through the sprayer400 of the adjustable nozzle of the apparatus containing thepharmaceutical formulation 200 will avoid the pitfalls of malabsorptionas the present forms do.

The pharmaceutical formulation 200 may contain an amount of dicyclomineranging in any amount from 0.1 mg to 1 g. In one aspect, thepharmaceutical formulation 200 contains 50 mg of dicyclomine. In oneaspect, the pharmaceutical formulation 200 contains an amount between 40mg and 60 mg of dicyclomine. The dicyclomine within the pharmaceuticalformulation 200 will be in a dry form so as to be able to be sprayed ina dry powder through the sprayer 400.

Dental powder is mixture of a variety of ingredients often to replacetoothpaste as a cleaning substance or mixed with medicines to facilitateadministration to an affected area. Dental powers may contain bakingsoda, herbs like cloves, mint, or cinnamon, and an artificial sweetenerfor taste.

The first use of dental powder was made from burnt eggshells mixed withpumice and the power of ox hooves' ashes. Later herbs, salt, and ginsengwere added to enhance the cleaning properties and taste of the powder.Some ancient powders used crushed bones and oyster shells to make agrittier powder. To prevent bad breath, the Romans also added powderedbark and charcoal to their teeth cleaner. Later, they created a mildersubstance using burnt snail shells, herbs, and honey.

Many dental powders contain baking soda as the key component. Thoughsome rudimentary powders still contained abrasive substances like brickdust, earthenware, and cuttlefish to thoroughly polish teeth. Laterborax was added to provide a cleansing, foaming effect and glycerinturns the powder into a paste.

Various modern dental powders are known in the art.

The dental powder will be added to the dyclonine HCL, triamcinolone, anddicyclomine so that the pharmaceutical formulation 200 is in powderedform and fit to be sprayed through the sprayer 400 and suctioned throughthe adjustable nozzle 300 of the bottle 100.

Dental powder may be provided in the pharmaceutical formulation 200 inany amount ranging between 0.1 g to 10 g. In one aspect, the amount ofdental powder in the pharmaceutical formulation 200 is 300 mg. In oneaspect, the amount of dental powder in the pharmaceutical formulation200 is an amount between 250 mg to 325 mg.

When the pharmaceutical formulation 200 is delivered by the apparatus,it applies a numbing agent (reduces pain), a low-potency steroid (helpsto reduce swelling), an anti-viral (to improve the cause), and coats theaffected area making it slick to improve the patients' short term andlong-term effects of having ulcers.

The delivery process is also one that will allow for ease of applicationof the medication to all areas of the mouth.

The dry powder dispenser accurately blows/lays the powder on to theaffected ulcer and begins to numb.

The apparatus and pharmaceutical formulation 200, or kit, allows for an“ouchless” application of the medication directly to the affected area.As with past ulcer OTC treatment such as cremes and mouth rinses werepainful and awkward to apply to the affected ulcer area. Ulcers in thevery back of the mouth, top of the gum line and under the tongue werenearly impossible to correctly apply cremes to. When applied correctly,the kit can reach the affected areas within the mouth and under thetongue with ease.

The kit may contain the pharmaceutical formulation 200 already mixed inthe bottle 100, or it may require a pharmacist to mix the pharmaceuticalformulation 200 from the active ingredients before dispensing the kit toa patient.

In order to mix the pharmaceutical formulation 200, a pharmacist shouldopen bottle 100 of Triamcinolone Powder 0.5 g, Acyclovir Powder 1.1 g,and Dicyclomine Powder 0.1 g.

Then the pharmacist will open the puffer dispenser and add all of thepowder contents of the triamcinolone to the puffer dispenser.

Then the pharmacist will tap all contents out of the vial; and then addall of the powder contents of the acyclovir to the puffer dispenser.

Then the pharmacist will tap all contents out of the vial; and shake thepuffer dispenser gently mixing the powders together.

Then the pharmacist will add all of the powder contents of thedicyclomine to the puffer dispenser.

Then the pharmacist will tap all contents out of the vial; and shake thepuffer dispenser gently mixing all of the powders together.

The compounded pharmaceutical formulation 200 may be stored atcontrolled room temperature, 15°−30° C. (59°−86° F.) [see USP].

The pharmaceutical formulation 200 should be disposed after 30 days ofbeing compounded.

In one aspect, the pharmaceutical formulation 200 contains dyclonineHCL, triamcinolone, dicyclomine, and dental powder. This pharmaceuticalformulation 200 will be in dry form so as to be able to be sprayedthrough the sprayer 400 of an apparatus.

In one aspect, pharmaceutical formulation 200 contains dyclonine HCL ina dry form in an amount between 75 mg and 125 mg, triamcinolone is anamount between 40 mg and 60 mg, dicyclomine is an amount between 40 mgand 60 mg, and dental powder is an amount between 250 mg and 325 mg, thepharmaceutical formulation 200 being in a dry powder form. The amount ofthese ingredients in this pharmaceutical formulation 200 should providetreatment of ulcers in the mouth for thirty days.

In one aspect, the dyclonine HCL is an amount of 100 mg, thetriamcinolone is an amount of 50 mg, the dicyclomine is an amount of 50mg, and the dental powder is an amount of 300 mg, the pharmaceuticalformulation 200 being in a dry powder form. The amount of theseingredients in this pharmaceutical formulation 200 should providetreatment of ulcers in the mouth for thirty days.

A person with ulcers will be able to apply the pharmaceuticalformulation 200 to treat an ulcer in their own mouth or in the mouth ofanother. A person with mouth ulcers will use an apparatus with a bottle100 that is filled with the pharmaceutical formulation 200 and willspray the pharmaceutical formulation 200 to the afflicted area.Preferably, the person will spray the afflicted area with one spray fourtimes a day for thirty days.

A person with a mouth ulcer or other mouth sore will be able to applythe pharmaceutical formulation 200 to treat an ulcer in their own mouthor in the mouth of another. A person with mouth ulcers will use anapparatus with a bottle 100 that is filled with the pharmaceuticalformulation 200 containing dyclonine HCL, triamcinolone, dicyclomine,and dental powder in a ratio of about 2:1:1:6 and will spray thepharmaceutical formulation 200 to the afflicted area. Preferably, theperson will spray the afflicted area with one spray four times a day forthirty days.

The present disclosure describes a kit containing an apparatus thatcontains a pharmaceutical formulation 200. The apparatus has a bottle100 with an adjustable nozzle 300, and a sprayer 400. FIG. 1 illustratesthe apparatus with the adjustable nozzle 300 in a closed position orstored position. This position does not allow the release of thepharmaceutical formulation 200 from the bottle 100. FIG. 2 illustratesthe apparatus with the adjustable nozzle 300 in an open position or inthe use position. This position allows the sprayer 400 to spray anamount of the pharmaceutical formulation 200 in dry form, which isdepicted in FIG. 3.

In one aspect, the pharmaceutical formulation 200 contains an oralanesthetic, a corticosteroid, an anticholinergics/antispasmodics, anddental powder. This pharmaceutical formulation 200 will be in dry formso as to be able to be sprayed through the sprayer 400 of an apparatus.In one aspect, the oral anesthetic is an amount between 75 mg and 125mg. In one aspect, the oral anesthetic is an amount of 100 mg. In oneaspect, the corticosteroid is an amount between 40 mg and 60 mg. In oneaspect, the corticosteroid is an amount of 50 mg. In one aspect, theanticholinergics/antispasmodics is an amount between 40 mg and 60 mg. Inone aspect, the anticholinergics/antispasmodics is an amount of 50 mg.In one aspect, the dental powder is an amount between 250 mg and 325 mg.In one aspect, the dental powder is an amount of 300 mg.

In one aspect, the pharmaceutical formulation 200 contains an oralanesthetic, a corticosteroid, an anticholinergics/antispasmodics, anddental powder in a ratio of about 2:1:1:6.

A person with ulcers will be able to apply the pharmaceuticalformulation 200 containing an oral anesthetic, a corticosteroid, ananticholinergics/antispasmodics, and dental powder to treat an ulcer intheir own mouth or in the mouth of another. A person with mouth ulcerswill use an apparatus that is filled with the pharmaceutical formulation200 and will spray the pharmaceutical formulation 200 to the afflictedarea. Preferably, the person will spray the afflicted area with onespray four times a day for thirty days.

A person with mouth ulcers will be able to apply the pharmaceuticalformulation 200 containing an oral anesthetic, a corticosteroid, ananticholinergics/antispasmodics, and dental powder to treat a mouthulcer, or other mouth sore, in their own mouth or in the mouth ofanother. A person with a mouth ulcer will use an apparatus with a bottle100 that is filled with the pharmaceutical formulation 200 containingoral anesthetic, a corticosteroid, an anticholinergics/antispasmodics,and dental powder in a ratio of about 2:1:1:6 and will spray thepharmaceutical formulation 200 to the afflicted area. Preferably, theperson will spray the afflicted area with one spray four times a day forthirty days.

It should be emphasized that the embodiments described herein are merelypossible examples of implementations, merely set forth for a clearunderstanding of the principles of the present disclosure. Manyvariations and modifications may be made to the described embodiment(s)without departing substantially from the spirit and principles of thepresent disclosure. Further, the scope of the present disclosure isintended to cover any and all combinations and sub-combinations of allelements, features, and aspects discussed above. All such modificationsand variations are intended to be included herein within the scope ofthe present disclosure, and all possible claims to individual aspects orcombinations of elements or steps are intended to be supported by thepresent disclosure.

One should note that conditional language, such as, among others, “can,”“could,” “might,” or “may,” unless specifically stated otherwise, orotherwise understood within the context as used, is generally intendedto convey that certain embodiments include, while alternativeembodiments do not include, certain features, elements and/or steps.Thus, such conditional language is not generally intended to imply thatfeatures, elements and/or steps are in any way required for one or moreparticular embodiments or that one or more particular embodimentsnecessarily include logic for deciding, with or without user input orprompting, whether these features, elements and/or steps are included orare to be performed in any particular embodiment. Unless statedotherwise, it should not be assumed that multiple features, embodiments,solutions, or elements address the same or related problems or needs.

Various implementations described in the present disclosure may includeadditional systems, methods, features, and advantages, which may notnecessarily be expressly disclosed herein but will be apparent to one ofordinary skill in the art upon examination of the following detaileddescription and accompanying drawings. It is intended that all suchsystems, methods, features, and advantages be included within thepresent disclosure and protected by the accompanying claims.

The invention claimed is:
 1. A kit comprising: an apparatus comprising abottle, an adjustable nozzle, a sprayer, and a dry powder formulationcomprising an amount of dyclonine HCL that is between 75 mg to 125 mg,an amount of triamcinolone that is between 40 mg to 60 mg, an amount ofdicyclomine that is between 40 mg to 60 mg, and an amount of dentalpowder that is between 250 mg to 325 mg.
 2. The kit of claim 1 whereinthe amount of dyclonine HCL is 100 mg.
 3. The kit of claim 1 wherein theamount of triamcinolone is 50 mg.
 4. The kit of claim 1 wherein theamount of dicyclomine is 50 mg.
 5. The kit of claim 1 wherein the amountdental powder is 300 mg.
 6. The kit of claim 1 wherein the formulationcomprises 100 mg of dyclonine HCL, 50 mg of triamcinolone, 50 mg ofdicyclomine, and 300 mg of dental powder.
 7. The kit of claim 1, whereinthe formulation is dyclonine HCL, triamcinolone, dicyclomine, and dentalpowder in a ratio of 2:1:1:6.